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Arab Pharmacovigilance Guidelines Course: Dubai, United Arab Emirates - October 21-22, 2019 - ResearchAndMarkets.com

DUBLIN

The "The Arab Pharmacovigilance Guidelines" conference has been added to ResearchAndMarkets.com's offering

On 1 July 2015, the Common Arab Guidelines on good vigilance practices became effective. The Guidelines represented fundamental changes to pharmacovigilance practice and followed the EU guidelines of June 2012.

This intensive two-day course will look at the various topics and their practical application from the perspective of the introduction of the EU guidelines. The course will include experiences of inspections and audits following implementation and will identify what the main focus points have been.

This interactive course will help you:

  • Gain an overview of the modules and the responsibilities of the MAH
  • Discuss the practical application of the modules and documentation required
  • Discover the levels of implementing quality systems throughout the company
  • Understand the regulatory expectations of inspections

Who Should Attend:

Anyone involved in pharmacovigilance and regulatory activities - including pharmacovigilance case processing, local QPPVs, medical directors, drug safety managers, QA auditing, PSUR writers, and any company managers and licence holders wanting to know what impact this will have on their business practices.

Agenda:

Programme - Day two

An introduction to the PV structure

  • Overview of the modules
  • The interaction of the modules
  • A comparison to the EU modules

Module I - quality management systems

  • Quality control, quality assurance, and quality management
  • Quality management of PV systems
  • QPPV and quality management
  • Quality and training
  • QA and quality management and internal audits

Module II - the pharmacovigilance system master file (PSMF)

  • The content of the PSMF
  • Licence submissions and the PSMF
  • The QPPV and the PSMF
  • Control/management of the PSMF

Module III - pharmacovigilance inspections

  • The purpose of the inspection
  • Types of inspection
  • Inspection findings
  • Re-inspections

Module IV - pharmacovigilance audits

  • The purpose of company audits
  • Audit scheduling and risk
  • Audit outputs and findings
  • Audit findings and their corrections - root cause analysis, corrective action plans, completion and re-audits
Programme - Day two

Module V - risk management plans (RMPs)

  • ICH E2E - pharmacovigilance planning
  • The RMP purpose
  • The RMP format
  • Updating the RMP
  • RMPs and REMs

Module VI - adverse reaction reporting (part 1)

  • Definitions
  • Special situations
  • Triage - seriousness
  • Expectedness and causality
  • Expedited reporting

Module VI - adverse reaction reporting (part 2)

  • Electronic ADR reporting - local and international
  • Follow-up of cases
  • ICH E2D - post-marketing safety
  • Literature ADR reporting
  • Case closure

Module VII - periodic safety update reports (PSURs)

  • ICH E2F and ICH E2C (R2) - DSRRs and PSURs/PBRERs
  • Objectives of the PSURs
  • Risk-benefit analyses in PSURs
  • The format of the PSUR
  • Mapping signals and risks to the PSUR

Module IX - signals and their management

  • What is a signal?
  • Signal validation
  • Signal analysis and prioritisation
  • Signal assessment
  • Actions to be taken

For more information about this conference visit https://www.researchandmarkets.com/r/4sh6lq

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

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